BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    PARI SINUS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GE LOGIQ A100 MP, MODEL 2272413

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    EVERFLO OXYGEN CONCENTRATOR

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS INC.·Product code CAW·February 26, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 17, 2026

    CR PROLONG 36MM BRNG STD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·May 31, 2022

    FIXATION BOLT GAMMA3 DISTAL TARGETING Ø9X50 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·May 3, 2013

    AUTO ENDO5 ML APPLIER

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code HBT·August 19, 2014

    MICRUS MICROCOIL SYSTEM

    FDA Adverse Event
    Injury ·MICRUS ENDOVASCULAR CORPORATION·Product code MJN·May 3, 2011

    COMP RVRS SHLDR GLNSP +6 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·July 12, 2021

    COMP RVRS SHLDR GLNSP STD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·July 9, 2021

    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012